Colonoscopy Preparation
Conditions
Keywords
Bowel Evacuation, Colonoscopy Preparation
Brief summary
The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.
Interventions
DRUG90 grams of Crystalline Lactulose
15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
DRUG135 grams of Crystalline Lactulose
15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
DRUG180 grams of Crystalline Lactulose
15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses
Sponsors
Cumberland Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients requiring bowel evacuation for colonoscopy.
Exclusion criteria
* Patients with galactosemia (galactose-sensitive diet). * Patients known to be hypersensitive to any of the components of lactulose for oral solution. * Patients with a known abnormality on screening or a vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts. * Patients with a history of impaired renal function. * Patients with current or recent history of hypotension, as defined by the Investigator. * Patients with a history of long Q-T syndrome. * Patients with a history of a failed bowel preparation. * Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives. * Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery (except hemorrhoidectomy and polypectomy). * Patients on lactulose therapy or receiving any treatment for chronic constipation. * Be pregnant or nursing. * Patients expected to require electrocautery or argon plasma coagulation. * Patients less than 18 years of age. * Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]) and agree to abide by the study restrictions. * Be otherwise unsuitable for the study, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. | 10-14 hours post last consumption | Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence | 1 day post last consumption | Safety determined by the incidence of treatment emergent adverse events. |
| Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | 1 day post last consumption | Safety determined by the severity of treatment emergent adverse events. |
| Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant | 1 day post last consumption | Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 90 Grams of Crystalline Lactulose 15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses | 8 |
| 135 Grams of Crystalline Lactulose 15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses | 12 |
| 180 Grams of Crystalline Lactulose 15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses | 12 |
| Total | 32 |
Baseline characteristics
| Characteristic | 90 Grams of Crystalline Lactulose | 135 Grams of Crystalline Lactulose | 180 Grams of Crystalline Lactulose | Total |
|---|---|---|---|---|
| Age, Continuous Subject Age at Enrollment | 47.4 years STANDARD_DEVIATION 6.2 | 57.0 years STANDARD_DEVIATION 7.4 | 58.1 years STANDARD_DEVIATION 8.7 | 55.0 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 12 Participants | 11 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 11 Participants | 10 Participants | 29 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 9 Participants | 21 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 8 | 4 / 12 | 6 / 12 |
| serious Total, serious adverse events | 0 / 8 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
Time frame: 10-14 hours post last consumption
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 90 Grams of Crystalline Lactulose | Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. | 5.7 units on a scale | Standard Deviation 2.8 |
| 135 Grams of Crystalline Lactulose | Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. | 7.4 units on a scale | Standard Deviation 0.9 |
| 180 Grams of Crystalline Lactulose | Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. | 7.8 units on a scale | Standard Deviation 0.8 |
Secondary
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
Safety determined by the incidence of treatment emergent adverse events.
Time frame: 1 day post last consumption
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 90 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence | 25 % of patients with adverse events |
| 135 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence | 33 % of patients with adverse events |
| 180 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence | 50 % of patients with adverse events |
Secondary
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
Safety determined by the severity of treatment emergent adverse events.
Time frame: 1 day post last consumption
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 90 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Moderate | 25 Percentage of subjects |
| 90 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Mild | 0 Percentage of subjects |
| 90 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Severe | 0 Percentage of subjects |
| 135 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Moderate | 8 Percentage of subjects |
| 135 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Mild | 25 Percentage of subjects |
| 135 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Severe | 0 Percentage of subjects |
| 180 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Mild | 50 Percentage of subjects |
| 180 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Severe | 0 Percentage of subjects |
| 180 Grams of Crystalline Lactulose | Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Moderate | 0 Percentage of subjects |
Secondary
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant
Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable
Time frame: 1 day post last consumption
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 90 Grams of Crystalline Lactulose | Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant | 65.4 units on a VAS scale | Standard Deviation 27.6 |
| 135 Grams of Crystalline Lactulose | Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant | 68.5 units on a VAS scale | Standard Deviation 19.6 |
| 180 Grams of Crystalline Lactulose | Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant | 71.3 units on a VAS scale | Standard Deviation 18.4 |